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Completed

NCT Number: NCT01478009

Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections

Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of Korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. The investigators sought to examine the efficacy of an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red ginseng will be investigated in healthy subjects during the influenza season.

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Key information

Conditions

Healthy Subjects

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

The extract of Korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. The investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, South Korea. The subjects will be instructed to take 9 capsules per day of either the Korean red ginseng extract or a placebo for a period of 12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms will be scored by subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 30-70 years old
  • have contracted at least 2 colds in the past year

Exclusion criteria

  • if they had been vaccinated against influenza in the previous 6 months.
  • Subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, HIV/AIDS, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities
  • Subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine
  • Abnormal liver or kidney function tests (ALT or AST>2 times the upper limit of normal; elevated creatinine, males>125uM/L, females>110uM/L)
  • pregnant or lactating women and heavy smokers.
  • being judged by the responsible physician of the local study center as unfit to participate in the study

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

Korean red ginseng(3.0g/day) for 12 weeks

Placebo

Dietary Supplement

Placebo (3.0g/day) for 12 weeks

Primary outcomes

  1. Frequency of ILI(Influenza Like Illness)

    Time frame: 12 weeks

    Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.

Secondary outcomes

  1. Symptom Severity of All Colds

    Time frame: 12 weeks

    Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone.

    Symptom severity of all colds (score 0-27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia).

    Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst).

  2. Total Number of Days of Symptoms and Duration of All Colds

    Time frame: up to 12 weeks

    Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

A Placebo-Controlled Trial of Korean Red Ginseng Extract to Prevent Acute Respiratory Illness in Healthy Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Dec 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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